CAFC Finds ANDA Infringement Despite Differences Between FDA Labeling And Claim Language

In a non-precedential decision issued in Braintree Labs., Inc. v. Breckenridge Pharmaceutical, Inc., the Federal Circuit reversed the district court’s grant of summary judgment of noninfringement in favor of Breckenridge, and remanded for entry of judgment in favor of Braintree. In reaching its decision, the court held Breckenridge to its previous stipulations, and found that proposed ANDA labeling for “colon cleansing” induced infringement of claims directed to “inducing purgation.” Continue reading this entry

USPTO Patent Term Adjustment Error Costs Patent Owners Time And Money

The USPTO appears to have dropped its plans to overhaul the Information Disclosure Statement (IDS) process, but that’s no excuse for its failure to process IDSs in accordance with its current rules. Most egregiously, the USPTO erroneously charges a Patent Term Adjustment (PTA) deduction for IDSs filed with a Rule 704(d) statement because its PTA calculation process fails to determine whether such a statement was included. While patent owners can file an application to be awarded that PTA, such an application requires a $200 fee–not to mention time to identify the error, prepare and file the petition, and ensure a Certificate of Correction is granted.

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Are Secret Sales Prior Art Under The AIA?

In Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit found that a publicly-announced “Supply and Purchase” agreement triggered the on-sale bar under pre-AIA 35 USC § 102(b) and under AIA 35 USC § 102(a)(1).  With this case, the court offered its first interpretation of the on-sale bar of the America Invents Act. Although the court did not address whether an entirely secret sale would qualify as prior art under the AIA, it decided that where the existence of the sale was made known to the public, the sale constitutes prior art even if the public disclosure did not reveal the invention. Continue reading this entry

How Will The Supreme Court Choreograph The Biosimilar Patent Dance?

On April 26, 2017, the Supreme Court heard oral arguments in Amgen v. Sandoz, where the parties have asked the Court to interpret two of the biosimilar patent dance provisions of the Biologics Price Competition and Innovation Act (BPCIA). While it is never wise to predict how the Justices will rule based on the questions and comments at oral hearing, I would not be surprised if they uphold the Federal Circuit’s interpretation of this complicated statute.  Continue reading this entry

No Nexus For Novartis Gilenya Patent

In Novartis AG v. Torrent Pharmaceuticals Ltd., the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) invalidating all claims of U.S. Patent 8,324,283, which is one of four Orange Book-listed patents for GILENYA. Among other issues, the court affirmed the PTAB’s finding that the asserted objective indicia of non-obviousness lacked sufficient nexus to the claimed invention to warrant a different outcome. Continue reading this entry